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Monday, September 24, 2018

Labs lose challenge to multi-billion Medicare cut


A group of clinical laboratories on Friday lost their legal challenge to a multibillion-dollar Medicare reimbursement cut.
U.S. District Judge Amy Berman Jackson dismissed the complaint Friday, saying the laboratories can’t challenge the lost reimbursement funding in court.
“While the court acknowledges that plaintiff’s arguments on the merits raise important questions … Congress expressly precluded judicial review of issues such as these, and the court has no jurisdiction to hear the case,” Jackson wrote in her decision.
The labs expect to lose $670 million this year after the CMS changed its pay rates to match private payer rates for the tests. The cut will equal $4 billion over 10 years.
The reimbursement change stemmed from the Protecting Access to Medicare Act of 2014. The switch was made final in a rule released last year and went into effect on Jan. 1.
The American Clinical Laboratory Association, a trade group for clinical labs, sued the CMS in December over the planned cuts, claiming the agency ignored congressional intent and instituted a flawed data-reporting process in advance of setting market rates under the law.
“This is an extremely disappointing outcome for ACLA’s members and the millions of seniors they serve—including the most vulnerable Medicare beneficiaries—who rely on clinical laboratory tests for their most basic health needs,” ACLA President Julie Khani said in a statement.
Industry groups have argued that the CMS set the pay rates based on data from labs with the biggest test volumes that receive the highest discounts from test manufacturers. If the CMS surveyed more labs, the groups claim the cuts would be much smaller.
Khani is concerned the change could cause serious financial harm to thousands of laboratories and make it harder for Medicare beneficiaries to get access to medical testing, particularly in remote rural areas and in nursing homes that depend on laboratory testing services.
The Congressional Budget Office, assuming more labs would be surveyed, estimated that the Protecting Access to Medicare Act would cut Medicare spending by $100 million in the first year of the new rates and by $2.5 billion over 10 years.
The ACLA and its members are considering appealing Judge Jackson’s ruling. For now, the trade group hopes Congress will reform and modernize the clinical lab fee schedule to address the issue.
Medicare’s fee schedule for lab tests has been largely unchanged since it was established in 1984. Each lab determines its own rates based on market prices. Medicare has historically paid 18% to 30% more than other insurers for some tests, HHS’ Office of Inspector General found. The program shells out about $7 billion a year for clinical diagnostic laboratory tests.
The clinical labs took issue with the CMS’ decision to exempt many labs from reporting what private insurance companies were paying for tests. The CMS said the decision was an attempt to reduce regulatory burdens. HHS’ Office of Inspector General initially estimated the rule would apply to approximately 12,000 laboratories, but only 2,000 reported data.

Tesaro initiated at Leerink


Tesaro initiated with an Outperform at Leerink. Leerink analyst Andrew Berens started Tesaro with an Outperform rating and $48 price target.

Loxo Oncology initiated at Leerink


Loxo Oncology initiated with an Outperform at Leerink. Leerink analyst Andrew Berens started Loxo Oncology with an Outperform rating and $205 price target.

Blueprint Medicines initiated at Leerink


Blueprint Medicines initiated with an Outperform at Leerink. Leerink analyst Andrew Berens started Blueprint Medicines with an Outperform rating and $105 price target. https://thefly.com/landingPageNews.php?id=2794745

Deciphera initiated at Leerink


Deciphera initiated at Leerink  Deciphera initiated with an Underperform at Leerink. analyst Andrew Berens started Deciphera Pharmaceuticals with an Underperform rating and $28 price target.

UnitedHealth tells Hospitals about Envision ER contracts


UnitedHealth (UNH) plans to treat emergency room and other hospital services performed by Envision Healthcare (EVHC) as out-of-network claims starting next year after failing to reach a new contract deal with the staffing company, Reuters reports, citing a letter sent by the health insurer to 300 hospitals. The move comes 90 days ahead of the January 1 date for the out-of-network switch, and after months of talks between the two companies to settle disagreements over payment rates and other financial incentives, the report says, citing UnitedHealth spokesman Stephen Shivinsky.
https://thefly.com/landingPageNews.php?id=2794771

Theravance Gets EU Panel Nod for Expanded COPD Indication for Med


Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD. Trelegy Ellipta is the triple combination therapy of FF/UMEC/VI in a single ELLIPTA® inhaler.

The expanded indication for the once-daily single inhaler triple therapy would enable use by patients not adequately treated by a long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA). It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study.
Trelegy Ellipta is a product in which Theravance Biopharma has an economic interest in future payments that may be made by GlaxoSmithKline (GSK) or one of its affiliates pursuant to its agreements with Innoviva (formerly Theravance, Inc.). Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%, resulting in cash flows to Theravance Biopharma of approximately 5.5% to 8.5% of worldwide net sales of Trelegy Ellipta.
Trelegy Ellipta is the first COPD treatment to provide a combination of three molecules in a single inhaler that only needs to be taken once a day. The unique combination treatment includes: FF, an inhaled corticosteroid (ICS); UMEC, a LAMA; and VI, a LABA. This combination has been formulated to be delivered once-daily in GSK’s ELLIPTA® dry powder inhaler.